Plain English Summary

Background and study aimsWhen we dont drink enough water for our needs, we become dehydrated. A number of studies have shown that dehydration can cause disability and even death in people of all ages. In older people, it can cause them to fall or become confused. It can also lead to poorer wound healing, infections, bad reactions to any drugs they are taking (drug toxicity) and a general poorer quality of life. Being able to quickly notice the signs of dehydration in older people, prevent it and treat it in the community would be beneficial to themselves and reduce NHS costs. Being able to measure dehydration, by assessing something called blood osmolality (the amount of salts and water in the blood) is not often available in residential care homes. We have created a simple tool to predict when a person is becoming dehydrated (a decision tree of tests). Our earlier study, DRIE, interviewed 200 older people living in care homes, assessed their hydration status and carried out a range of tests and assessments that might help to find out how hydrated they are. We analysed these data on potential signs, conditions and tests, and found that no single test or sign was capable of diagnosing dehydration on its own. It is from these results that we have made several possible decision trees that would be used to identify dehydration. Decision trees can accurately predict how hydrated someone is without the need for a lot of tests for the person themselves. This study (DRIE 2) will test the best two decision trees on another 200 older people living in residential care homes.

Who can participate? People aged 65 or over, who are living in residential care (care homes, nursing homes and mixed homes) including people with dementia.

What does the study involve? This study will test how well the best two decision trees predict dehydration in older people in care homes. We will test for dehydration by measuring blood osmolality, carry out all the assessments needed for the decision trees and collect relevant health and demographic information. We will use these data to assess how accurately our diagnostic trees are at identifying whether a person is dehydrated.

What are the possible benefits and risks of participating? Benefits: The knowledge that you are helping other older people by helping us to recognise dehydration and a £10 voucher or equivalent for attending each of the two interviews.Risks: The blood test could be slightly painful, and could cause bleeding or bruising.

Where is the study run from? A number of residential care homes on Norfolk or Suffolk (UK).

When is the study starting and how long is it expected to run for?From May 2014 to end of April 2015

Who is funding the study? The National Institute for Health Research (NIHR), UK

Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Norwich Medical School University of East Anglia Norwich Research Park Norwich NR4 7TJ United Kingdom
+44 (0)1603 591268l.hooper@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR-CDF-2011-04-025

Study information

Scientific title

Testing of a simple tool for diagnosis of water-loss dehydration: a diagnostic accuracy study

Acronym

DRIE 2

Study hypothesis

A short decision tree can usefully assess the presence of dehydration in older people living in care homes.

Ethics approval

Our ethics approval was granted completely (with the an acknowledgement of additional conditions letter) on 29th April 2014 following the favourable opinion with additional conditions letter issued on 25 April 2014, by WALES REC 7, reference 14/WA/0145.

Study design

Cross-sectional diagnostic accuracy study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

Intervention

We will test for water-loss dehydration (through blood osmolality) and also carry out the assessments needed for the decision trees, as well as collecting health and demographic information. We will use these data to assess diagnostic accuracy of the proposed decision trees to diagnose or rule out dehydration.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

We will be assessing whether our simple decision tree usefully predicts dehydration in care home residents.

Secondary outcome measures

1.Assessing the acceptability and invasiveness of the individual assessments to older people living in residential care2.To assess the relationship between nutritional status (assessed by change in weight over the past 6 months, body mass index, Mini Nutritional Assessment, Malnutrition Universal Screening Tool, haemoglobin) and hydration status in care home residents.3. Assessing some additional promising clinical and/or physical signs or questions (such as assessing foot skin turgor, dry lips, asking participants whether they feel out of sorts, and whether they drink as much as they need to stay healthy, completing the mini-mental state exam, observing whether participants taste their drink immediately and recording their Barthel score and number of medications prescribed) so that if the current decision tree does not prove useful we have a strong evidence base (from 200 participants in the DRIE study, and a further 200 participants in DRIE 2) to allow development of a better decision tree.

Overall trial start date

01/05/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. People aged 65+ living in residential care (care homes, nursing homes and mixed homes) in Norfolk or Suffolk (UK).2. We will include participants regardless of their capacity to provide informed consent, although the study is designed to protect all participants and include them only if they find the research acceptable.3. Inclusion of those with dementia was strongly encouraged by the NIHR interview panel that awarded the funding for this research, as those with dementia are at greatly increased risk of dehydration, so it is vital that the tool developed is applicable to those with dementia as well as those without. This decision has been strongly supported by care home managers and staff before and during the course of the original DRIE study. We will only include adults who can provide their own informed and signed consent OR whose consultee has provided signed consent that they believe that the resident would have consented if they were able to make the decision themselves.4. We do not plan to stratify inclusion by age group (as most of those living in residential care will be either physically or mentally frail, all will be at some increased risk of dehydration), or by gender (although the samples are likely to be weighted towards women, as more care home residents are women). While we are aiming for a representative sample of care home residents, we will not exclude any interested participants on this basis. Our sample of care home residents is likely to be rather less frail than the average resident as those with better physical and cognitive capacities are more likely to feel able to participate, but we will collect a small amount of data on all residents in the homes we work in to assess the representativeness of our study sample.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Those who the care home manager is aware have been diagnosed with renal failure or heart failure, as fluid physiology changes with these conditions (and fluid retention is more likely).2. Those in receipt of palliative care, or with illnesses that suggest they are unlikely to survive for at least 3 months will not be recruited. 3. Who are unable to provide their own consent, and are known to be frightened of, or upset by, needles or blood tests as we will assume that the process of the interview and blood sample will be upsetting to them.